Promising Topical Nail Fungus Treatment Performs Well in Phase 3

Hard-to-treat toenail fungus is one side effect of diabetes, a condition brought by decreased circulation and increased susceptibility to infection. The condition, called onychomycosis, afflicts some 35 million people in the United States.

The fungus is extremely hard to treat. While there are several over-the-counter topical treatments for onychomycosis, they are not particularly effective. They require months of application to produce even minor improvements, and all but one are not FDA-approved.

New laser-based treatments are very effective at destroying the fungus without surgery and producing dramatic results in most people who undergo the out-patient treatment. But the cost is high–hundreds of out-of-pocket dollars since few insurance companies compensate for the still novel treatments.

Some people do resort to surgical intervention to eradicate the fungus and allow healthy new nails to grow, the step is so radical that few people who suffer from onychomycosis take it.

Options could soon change: Palo Alto, Calif.-based Anacor Pharmaceuticals has announced that its topical treatment for toenail fungus, called tavaborole, achieved statistically significant results in two Phase 3 studies. As a result, it is now seeking FDA approval to market the treatment.

Anacor describes tavaborole as an easily applied, fast-drying boron-based topical treatment that penetrates nails and binds to the fungus more effectively than any current treatment. Anacor conducted two separate Phase 3 studies of tavaborole on patients with distal subungual onychomycosis affecting 20 to 60 percent of the target great toenail. Approximately 600 patients aged 18 years and older were enrolled in each study and randomized two-to-one to receive either tavaborole or placebo. Patients applied tavaborole solution or placebo to the toenail once daily for 48 weeks.

The company says Phase 3 results “achieved statistically significant and clinically meaningful results on all primary and secondary endpoints in two Phase 3 pivotal studies without concomitant debridement” (the removal of nonviable material, foreign bodies, and poorly healing tissue from a wound). It reported that most test subjects achieved clear to almost clear nails and elimination of the infection without the need for medical removal of the damaged nail and nail bed.

The company’s website has more information about the treatment: www.anacor.com/an2690.php

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